Lung Cancer Clinical Trial

A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

Summary

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed squamous NSCLC
Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments

Exclusion Criteria:

Nonsquamous NSCLC
Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
Previous chemotherapy for NSCLC
Major surgery or received any investigational therapy in the 4 weeks prior to randomization
Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

167

Study ID:

NCT01769391

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 51 Locations for this study

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jonesboro Arkansas, 72401, United States
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Los Angeles California, 90048, United States
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Sacramento California, 95816, United States
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Colorado Springs Colorado, 80907, United States
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Fleming Island Florida, 32003, United States
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Fort Myers Florida, 33916, United States
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Miami Beach Florida, 33140, United States
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Port Saint Lucie Florida, 34952, United States
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Saint Petersburg Florida, 33705, United States
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Macon Georgia, 31201, United States
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Marietta Georgia, 30060, United States
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Savannah Georgia, 31404, United States
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Valdosta Georgia, 31602, United States
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Wichita Kansas, 67214, United States
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Louisville Kentucky, 40202, United States
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Kalamazoo Michigan, 49007, United States
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Lansing Michigan, 48910, United States
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Woodbury Minnesota, 55125, United States
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Billings Montana, 59101, United States
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Lincoln Nebraska, 68510, United States
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Cherry Hill New Jersey, 08003, United States
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Hackensack New Jersey, 07601, United States
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Latham New York, 12110, United States
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Cincinnati Ohio, 45242, United States
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Eugene Oregon, 97401, United States
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Charleston South Carolina, 29425, United States
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Columbia South Carolina, 29210, United States
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Chattanooga Tennessee, 37404, United States
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Memphis Tennessee, 38120, United States
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Nashville Tennessee, 37203, United States
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Fort Worth Texas, 76104, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
The Woodlands Texas, 77380, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Richmond Virginia, 23230, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Großhansdorf , 22927, Germany
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Heidelberg , 69126, Germany
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Immenhausen , 34376, Germany
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Münster , 48149, Germany
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Incheon , 405-7, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Ulsan-Si , 682-7, Korea, Republic of
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Chihuahua , 31000, Mexico
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Leon , 37000, Mexico
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Mexico City , 6700, Mexico
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Monterrey , 64000, Mexico
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Glucholazy , 48-34, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Olsztyn , 10-35, Poland
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Otwock , 05-40, Poland
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Poznan , 60-69, Poland
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Radom , 26-61, Poland
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Warsaw , 02-78, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg , 19429, Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

167

Study ID:

NCT01769391

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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